First At-Home Genetic Test For Breast Cancer Risk Approved

The FDA has approved the first at-home genetic test for breast cancer risk. For the first time, the agency authorized 23andMe’s test for 3 BRCA1/BRCA2 breast cancer mutations, which are most common among Ashkenazi Jews.

After DNA analysis from a self-collected saliva sample, the results then detail whether a woman is at an increased risk of developing breast and ovarian cancer and whether a man is at an increased risk of developing breast or prostate cancer. It is important to note that the test only detects 3 out of the more than 1,000 known breast cancer mutations. Furthermore, only a small percentage of Americans carry one of these 3 mutations. Most breast cancer mutations that increase a person’s risk are not detected by this test.

Therefore, you are not completely out of harm’s way if you test negative for the 3 mutations. Due to the mentioned caveats, the agency indicated that patients should not solely rely on this test, nor should the test be used to determine a cancer treatment. Additionally, the FDA says that this test should not substitute for a doctor visit because it doesn’t account for every possible outcome.


Alanna McCatty

Alanna McCatty

Alanna McCatty is founder and CEO of McCatty Scholars, an organization that devises and implements financial literacy programs for students to combat the nationwide issue of the loss of educational opportunity due to the ramifications of burdensome student debt. At MedShadow, she reports on new findings and research on the side effects of prescription drugs. She is a graduate of Pace University.


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